Effect of Age and Weight Loss on Inflammation and Iron Homeostasis (HEP)
12 de noviembre de 2015 actualizado por: Simin Meydani, Tufts University
Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women
The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women.
Iron deficiency and immune impairment are two of the numerous complications of obesity.
The central hypothesis is that obesity-induced inflammation causes lower iron status through decreased iron absorption and availability in young and older obese women.
Furthermore, the investigators hypothesize that this can be corrected with weight loss in both young and older obese women.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Obese individuals have chronic inflammation, higher risk of iron deficiency, and impaired immune response.
These are conditions seen also with aging, but it is unknown to what extent they may be further impacted by obesity in the elderly.
With this study the investigators aim to establish the mechanism by which weight loss may reduce inflammation and enhance iron status in young and older obese adults through the peptide hormone hepcidin, which regulates iron homeostasis.
The investigators also aim to identify a possible link between iron homeostasis and immune response through hepcidin, which has been implicated in T cell mediated immunity.
The investigators hypothesize that obesity-induced inflammation causes dysregulation of hepcidin expression leading to lower iron status through decreased iron absorption and availability in young and older adults.
Furthermore, the investigators hypothesize that hepcidin dysregulation, and thus iron status can be mitigated with weight loss in both young and older obese adults.
This hypothesis will be tested in obese young and older women undergoing weight loss through calorie restriction.
Change in iron status, inflammation, and hepcidin will be determined before and after weight loss.
Further, the impact of inflammatory environment of obesity on peripheral blood mononuclear cell hepcidin, ferroportin, intracellular iron, and T cell function in young and older adults will be determined.
This study will address two important public health problems, i.e. obesity and iron deficiency and will be an important step toward the identification of strategies to enhance health of obese young and older adults.
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- JM USDA Human Nutrition Research Center on Aging
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Enrolling patients in the Weight and Wellness Center (WWC) at Tufts Medical Center, part of their Tufts Employees, low calorie diet (LCD) or pre-surgical low calorie diet (PS-LCD) program, or enrolling at WWC as individual patients.
- BMI in the range of 30 to 55 kg/m2.
- Either ages 18-45 or >60.
Exclusion Criteria:
- Pregnancy.
- Weight reduction greater than or equal to 3% in the past 3 months.
- Prior gastric restrictive surgery.
- Weight loss medications within the 4 weeks prior to screening.
- History of eating disorder.
- Renal disease (serum creatinine >2mg/dl).
- Hepatic disease, except for nonalcoholic steatohepatitis (NASH).
- Celiac disease, or any kind of intestinal malabsorption disorders.
- Gastrointestinal cancer.
- Hereditary hemochromatosis, or any blood disorders.
- Chronic infectious or inflammatory disease.
- Use of immunosuppressants.
- Severe iron deficiency anemia (hemoglobin<8 g/dl) or other conditions that would prevent them from discontinuing iron supplement use.
- Unwilling to discontinue iron supplement intake. The dietary plan recommended by the WWC will include daily intake of iron that meets the iron RDA for the subject's gender and age group, therefore discontinuing iron supplement will not be harmful for the participants. Intake of other supplements will not be an exclusion criteria, as long as it stays constant throughout the study period.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Young (18-45 years)
Obese young women (18-45y) undergoing calorie restriction.
|
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
|
|
Experimental: Older (>60 years)
Obese older women (>60y) undergoing calorie restriction.
|
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in serum hepcidin
Periodo de tiempo: Baseline and 12-16 weeks
|
The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
|
Change in inflammation (CRP, IL-6)
Periodo de tiempo: Baseline and 12-16 weeks
|
The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
|
Change in iron status
Periodo de tiempo: Baseline and 12-16 weeks
|
The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in PBMC intracellular iron content
Periodo de tiempo: Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC Hepcidin expression
Periodo de tiempo: Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC ferroportin expression
Periodo de tiempo: Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC subpopulations and proliferation
Periodo de tiempo: Baseline and 12-16 weeks
|
After stimulation with ConA, PHA and anti-CD3/CD28
|
Baseline and 12-16 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Simin N Meydani, DVM, PhD, Tufts University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2011
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
5 de julio de 2012
Publicado por primera vez (Estimar)
10 de julio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
12 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2765
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .